Data from EUDAMED, last updated Jun 11, 2026

"H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)"

B-697424646HP000FQHZ

1 reference

IVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.

Device family identification

Device name: "H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)"
Basic UDI-DI: B-697424646HP000FQHZ
Issuing agency: EUDAMED
Version date: May 22, 2026

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category: IVDD — General
Status: On the market

ReagentProfessional testingAnimal tissues / cells

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

References

1 reference

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
"H.pylori Antibodies Rapid Test Kit (Whole Blood/serum/plasma)"	`HPAb-4011/HPAb-4012`	`D-697424646HP000FQHZ`	1	On the market